Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Mefenamic acid
Chemidex Pharma Limited
M01AG; M01AG01
Mefenamic acid
500 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Fenamates; mefenamic acid
Marketed
1997-01-24
PACKAGE LEAFLET: INFORMATION FOR THE USER PONSTAN FORTE 500 MG FILM-COATED TABLETS mefenamic acid IR1-2/L/x/1 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT PONSTAN FORTE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN FORTE 3. HOW TO TAKE PONSTAN FORTE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PONSTAN FORTE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PONSTAN FORTE IS AND WHAT IT IS USED FORE d for Ponstan Forte tablets contain mefenamic acid which is a non-steroidal anti-inflammatory drug (NSAID). They can help to relieve: symptoms of inflammation, such as redness and swelling pain and discomfort caused by arthritis, muscular or rheumatic disorders headache or toothache pain after operations, trauma childbirth pain painful or heavy periods symptoms of premenstrual syndrome (PMS). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN FORTE 2. BEFORE YOU TAKE DO NOT TAKE PONSTAN FORTE: if you are allergic to mefenamic acid, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or any of the other ingredients of this medicine (listed in section 6) if you have, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach, intestines or bowel, or severe gastritis, especially if you have taken NSAIDs before if you have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) if you have severe heart, liver or kidney problems if you ar Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ponstan Forte 500 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg mefenamic acid Excipients with known effect: Each film-coated tablet contains 22.73 mg lactose monohydrate, 0.067 mg Sunset yellow (E110) and less than 1 mmol sodium (23 mg) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. (Tablet) Ovoid tablets with yellow film-coating inscribed ‘PONSTAN FORTE’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As an anti-inflammatory analgesic for symptomatic relief of mild to moderate pain associated with rheumatic, muscular or arthritic disorders (including rheumatoid arthritis and osteoarthritis), trauma, headache, dental pain, post-operative or post-partum states. 2. In the management of dysfunctional menorrhagia. 3. Primary dysmenorrhoea. 4. Premenstrual syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms_ (see section 4.4, Special warnings and precautions for use)._ _ADULTS:_ The usual total daily dosage is 1500 mg in divided doses. _ELDERLY:_ NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events, especially with long-term use. Therefore, the risks versus the benefits of chronic therapy in the elderly should be carefully considered. The lowest dose compatible with adequate safe clinical control should be employed_ (see section 4.4,_ _Special warnings and precautions for use)._ Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. _CHILDREN:_ Not recommended for children under 12 years of age. Do not exceed the stated dose. Ponstan should be taken preferably with or after food. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document